BAROSTIM NEO Hypertension Pivotal Trial

Uncontrolled Hypertension Clinical Trial

Official title:

BAROSTIM NEO Hypertension Pivotal Trial

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01679132
• Other study ID #: 360039
• Status: Suspended
• Phase: N/A
• Start date: April 12, 2013
• Est. completion date: March 2026

Study information

• Verified date: April 2023
• Source: CVRx, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical investigation (NCT01679132) is to assess the long-term safety and efficacy of the BAROSTIM NEO System in subjects currently participating in the BAROSTIM Hypertension Pivotal Trial (G120137).

Description:

The BAROSTIM NEO Hypertension Trial is a prospective, randomized, controlled trial assessing the safety and efficacy of the BAROSTIM NEO System in subjects with resistant hypertension.

All subjects are now in long term follow-up and are required to have at least one annual visit.

Parameters assessed during visits are:

• Office Cuff Blood Pressure

• Physical Assessment

• Subject Medications

• Serious adverse events

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 10
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

• Actively participating in the Barostim Hypertension Pivotal Trial and currently implanted with the BAROSTIM NEO device with the device turned ON.

• Have signed a revised approved informed consent form for continued participation in this study.

Exclusion Criteria:

• Treating physician decision that the subject should not continue with therapy.

Related Conditions & MeSH terms

• Hypertension
• Uncontrolled Hypertension

Intervention

Device:
• BAROSTIM NEO System and Medical Management
Experimental: Device and Medical Management Subjects have been implanted with the BAROSTIM NEO System and receive optimal medical management, including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics; Thiazide Diuretics; Potassium-sparing Diuretics; Aldosterone receptor blockers; Beta-blockers; Beta-blockers with intrinsic sympathomimetic activity; Combined alpha- and beta-blockers; ACE inhibitors; Angiotensin II antagonists; Calcium channel blockers- non-Dihydropyridines; Calcium channel blockers- Dihydropyridines; Alpha1-blockers; Central alpha2-agonists and other centrally acting drugs; Direct vasodilators.

Locations

Country	Name	City	State
United States	Cardiovascular Institute of the South	Houma	Louisiana
United States	University Medical Center of Southern Nevada	Las Vegas	Nevada
United States	University of Southern California	Los Angeles	California
United States	Florida Hospital	Orlando	Florida
United States	Cardiac and Vascular Research Center of Northern Michigan	Petoskey	Michigan
United States	Arizona Heart Rhythm Research Center	Phoenix	Arizona
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Michigan CardioVascular Institute	Saginaw	Michigan
United States	Tampa General Hospital	Tampa	Florida
United States	George Washington University	Washington	District of Columbia
United States	Aspirus Wausau Hospital	Wausau	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
CVRx, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess long-term adverse events in subjects implanted with the BAROSTIM NEO System.	Ascertain the type, frequency, severity and timing of long-term adverse events in G120137 study subjects implanted with the device, while providing a viable treatment option to patients currently implanted with the CVRx BAROSTIM NEO System.	For the duration of the study, up to ten years.